P4 | Transforming a Community Health-Based Research Organization: Strategy and Lessons Learned

Learn about Mercy Research’s strategy in becoming a dedicated, centralized, fully integrated research organization within Mercy, a top five, large community health system headquartered in St. Louis, MO with operations in four states

Gain insight into Mercy Research’s Supersite™ strategy and its value to clinical researchers and sponsors

In the context of those strategies, hear about real-life challenges and lessons learned regarding (1) IRBs, (2) centralized regulatory and business operations, (3) standard start-up, business and clinical processes, and (4) change management

Monday, June 4

SESSION

SPEAKER

General Session 1 | Research Year In Review

This session is designed to cover all new laws, regulations and guidance promulgated by the government in the area of research

The session will outline new research related enforcement initiatives and settlements by the Department of Justice and the Office of Inspector General

The speaker will describe the implications of these laws, regulations and guidance on research programs and will suggest affirmative actions to be considered to strengthen research compliance programs for universities, academic medical centers, hospitals, CROs and other research organizations

Schedule I Controlled Substances such as marijuana and Ecstasy show promise in treating certain conditions like epilepsy and PTSD, but, by law, these substances are considered to have no medicinal use. How can they be used in clinical trials?

This session will help attendees understand how to legally conduct these trials, including working with regulators, obtaining controlled substances for research, establishing security protocols, and properly disposing of test articles

Human subjects research considerations, planning for adverse events, and communications strategies regarding these controversial studies also will be discussed

201 | Community Hospital Research Programs: A Compliance Officer’s Friend or Nightmare

Building a successful research program in a community hospital setting can be a disaster or a delight for a compliance officer depending on the level of collaboration in building/perfecting the model

Often research was not on the Compliance Officer’s radar until processes were already in place. But a collaborative approach to FDA/OHRP Regulations, Research Billing, COI, Quality Controls, FMV, Stark and Sunshine Act Concerns will yield best practices

402 | Integrating Research Integrity with Corporate Compliance

Consider how research integrity fits within enterprise risk management for academic medical institutions. Acknowledge the risk profile of colleges, universities, and other recipients of public funds that conduct biomedical and behavioral research. Confirm current expectations from government stakeholders

Identify the basic elements of a compliance program—and affiliated research integrity offices

Share the value proposition of integrating research integrity compliance within the culture’s broader values and code of conduct to encourage reporting and corrective action. Understand the elements of a mature, integrated, effective program—suggest approaches to measure effectiveness

Tuesday, June 5

SESSION

SPEAKER

General Session 8:15 – 9:15 am

General Session 3 | The Revised Common Rule: What Should We Do Now

The past few years have seen a previously-unprecedented level of change to Federal statutes, regulations, and policies applicable to human subjects research. These include the substantial changes to the “Common Rule,” the Federal regulations that protect human subjects in research. The session will:

Describe significant recent developments in the Federal regulation of human subjects research, focusing on the revised Common Rule

Address the challenges involved with integrating the revised Common Rule’s new mandates and flexibilities within the existing system of Federal law and policy

Identify decision points for regulated entities working toward implementation of the revised Common Rule

John R. Baumann, PhD, Associate Vice President for Research Compliance, Indiana University

802 | Outcome Unknown: The Ethics and Mechanics of Informed Consent in Research Involving Genomics, Questionable Pre-clinical Results, and the Risk of Death

The Current and Revised Common Rule framework for obtaining Informed Consent

Ethics of obtaining Informed Consent for research that involves the unknown and currently unknowable, including genomic research, future undefined research, significant risk studies involving death as a risk

Case study: When a healthy volunteer died in a European clinical trial for a new FAAH Inhibitor pain and mood disorder medication, the Temporary

Specialist Scientific Committee’s call for further clarification regarding use of healthy volunteers in light of troubling animal study results

Wednesday, June 6 | Post-Conference

SESSION

SPEAKER

8:30 – 10:00 am Breakout Sessions

W1 | A Case Study of the Implementation Process

Presenters will review the infrastructure and activities presented and recommended at the HCCA Research Conference and describe how the conference program recommendations were assessed for applicability in their entity’s environment

Presenters will describe how program recommendations were prioritized for implementation and staged for rollout

The presenters will describe obstacles encountered and solutions deployed to overcome prioritize activities and overcome challenges to enhancing research compliance program activities